Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects

Dynamic Hyperinflation Clinical Trial

Official title:

Dynamic Hyperinflation During Maximal Voluntary Ventilation in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831465
• Other study ID #: B076201318918
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2016
• Last updated: February 1, 2017
• Start date: April 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Audrey Herpeux
• Phone: 003225067323
• Email: audrey_herpeux[@]stpierre-bru.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Maximal Voluntary Ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation.

The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.

Description:

Maximal voluntary ventilation (MVV) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in COPD (Chronic Obstructive Pulmonary Disease) patients. Dynamic hyperinflation (DH) often occurs during MVV in COPD and is believed to be due to expiratory flow limitation. The present study is intended to assess whether DH can also occur during MVV in normal subjects without expiratory flow limitation.

Study design: healthy subjects with normal lung function will perform MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) will be measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeares at a given frequency, only one additional MVV at a higher breathing frequency will be conducted to confirm DH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• History of asthma, obstructive syndrome on basic lung function

Related Conditions & MeSH terms

• Dynamic Hyperinflation

Intervention

Behavioral:
• Healthy Subjects
Subjects with normal lung function performed MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) was measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeared at a given frequency, only one additional MVV at a higher breathing frequency was conducted to confirm DH.

Locations

Country	Name	City	State
Belgium	CHU St. Pierre	Brussels	Brussels Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency which induces Dynamic Hyperinflation	We analyze Frequency of Maximal Voluntary Ventilation (MVV) which induces a significant decrease of the Inspiratory Capacity (IC) post MVV compared to the IC at rest.	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Forced Expiratory Volume in one second	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Vital Capacity	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Forced Vital Capacity	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Forced Expiratory Flows at 25%, 50% and 75% of Forced Vital Capacity	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Forced Expiratory Flows at 25%, 50% and 75% of Forced Vital Capacity	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and age	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and age	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and body mass index	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and body mass index	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and Inspiratory Capacity at rest	We analyzed if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and Inspiratory capacity at rest	day one
Secondary	Correlation between the frequency which induces Dynamic Hyperinflation (DH) and IC/FVC ratio (IC : Inspiratory Capacity at rest ; FVC : Forced Vital Capacity)	We analyze if there is a good correlation between the frequency which induces a significant Dynamic Hyperinflation (DH) and IC/FVC ratio (IC : Inspiratory Capacity at rest ; FVC : Forced Vital Capacity)	day one
Secondary	Comparison Maximal Voluntary Ventilation with Forced Expiratory Volume in one second multiplied by 35	We compare Maximal Voluntary Ventilation at the different frequencies with the common predictive value of maximal ventilation obtained by multiplying Forced Expiratory Volume in one second by 35	day one